Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code BUD

16. Specific lobbying issues

H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328) - various funding levels; FDA provisions
H.R. 3932: PASTEUR Act of 2021- To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections
H.R. 4121, PRO Seniors Act, provisions related to drug rebates
H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169), prescription drug provisions
H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180)
H.R. 7900: National Defense Authorization Act for Fiscal Year 2023
H.R. 8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2023
H.R. 8256: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2023
H.R. 8295: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023
S. 2076: PASTEUR Act of 2021- To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections
S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023
FY 2023 Presidents Budget Request
National Coverage Determination (NCD) for Apretude (cabotegravir long-acting [CAB-LA] for Pre-Exposure Prophylaxis [PrEP])
PAHPA Reauthorization
Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Management & Budget (OMB)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CPT

16. Specific lobbying issues

H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs
H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights
H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents
H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement
H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections
H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections
S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs
S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity
S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents
S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy
S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency
S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes
S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes
S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matter relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes
S. 4430: Interagency Patent Coordination and Improvement Act of 2022
S. 4704: Patent Examination and Quality Improvement Act of 2022
S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues
Biopharmaceutical innovation and patent policy issues
Bayh-Dole march-in rights policy issues

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HCR

16. Specific lobbying issues

H.R. 623: Gabriella Miller Kids First Research Act 2.0
H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process
H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation
H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines
H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research
H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products
HR 1978 - Protecting Seniors Through Immunization Act
H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation
H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research
H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals
H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions
H.R. 3761: Promising Pathways Act - Provisions related to FDA policy
H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues
H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program
H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy
H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act 
H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone
H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169)
H.R. 5416: Give Kids a Chance Act
H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research
H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance
H.R. 6000: Cures 2.0 Act - Provisions related to health research
H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes
H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property
H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval
H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations
H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling
H.R. 7008: Pre-Approval Information Exchange Act of 2022  
H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act
H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes
H.R. 7845: NIH Clinical Trial Diversity Act of 2022
H.R. 7900: National Defense Authorization Act for Fiscal Year 2023
H.R. 8152: American Data Privacy and Protection Act
S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process
S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products
S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation
S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions
S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program
S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation
S. 1425: Stop STALLING Act - Provisions related to citizen petitions
S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals
S. 1644: Promising Pathway Act - Provisions related to FDA policy
S. 1645: ADAPT Act - Provisions related to FDA policy
S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues
S. 2706: DIVERSE Trials Act - Provisions related to FDA policy
S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program
S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways
S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act
S. 4215: Give Kids a Chance Act of 2022
S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes
S. 4430: Interagency Patent Coordination and Improvement Act of 2022
S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022
S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues
Cancer Moonshot Initiative
21st Century Cures 2.0
Department of Homeland Security cybersecurity policy issues
Drug cost and pricing policy issues
Principles for drug pricing reform
Drug importation policy issues
Drug counterfeiting policy issues
Direct to consumer advertising policy issues
Competition policy issues
Orphan Drug Act policy issues
Expanded access policy issues
Antimicrobial resistance (AMR) policy issues
Mental health policy issues
High deductible health plans/HSA policy issues
Supply chain and foreign manufacturing policy issues
Real world evidence policy issues
Clinical trial diversity policy issues
Prescription drug abuse and fentanyl policy issues
340B drug discount program policy issues
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Drug shortages policy issues
COVID-19 policy issues
Pandemic preparedness policy issues
Issues related to HFC's
Defense Production Act (DPA) policy issues
Final Rule; Importation of Prescription Drugs
Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022)
Veterans' Affairs issues related to product sampling
Provisions related to the importation of HFCs, necessary for MDI production.
P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing
PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Office of Management & Budget (OMB)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MMM

16. Specific lobbying issues

Executive Order on Lowering Prescription Drug Costs for Americans (October 4, 2022)
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property
H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs and drug pricing
H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference
H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169); provisions related to drug pricing
S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access
S. 4293: Pharmacy Benefit Manager Transparency Act of 2022
S. 2416: NOVEL Act of 2021 - Provisions related to novel medical products
Part D redesign and policy issues including non-interference and rebates policy issues
Part B policy issues
Drug cost and pricing policy issues
Rebate policy issues
Pharmacy Benefit Manager reform and policy issues
Value-based purchasing arrangements policy issues
Anti-Kickback Statute policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and waiver policy issues
Notice of Benefit and Payment Parameters (NBPP)

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Centers For Medicare and Medicaid Services (CMS), Office of Management & Budget (OMB)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TRD

16. Specific lobbying issues

H.R. Res. 1285 - WTO TRIPS Waiver Resolution, Waiver Expansion
H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains
H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing
H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade NegotiatorS. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains
S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains
S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
Biopharmaceutical innovation policy issues
International intellectual property and market access policy issues
Pricing and reimbursement policy issues
Supply chain policy issues
WTO TRIPS waiver

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, U.S. Trade Representative (USTR)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

22. New General description of client’s business or activities

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
No Yes